title: Formulated collagen gel accelerates healing rate immediately after application in patients with diabetic neuropathic foot ulcers.
abstract: We assessed the safety and efficacy of Formulated Collagen Gel (FCG) alone and with Ad5PDGF-B (GAM501) compared with Standard of Care (SOC) in patients with 1.5-10.0 cm(2) chronic diabetic neuropathic foot ulcers that healed <30% during Run-in. Wound size was assessed by planimetry of acetate tracings and photographs in 124 patients. Comparison of data sets revealed that acetate tracings frequently overestimated areas at some sites. For per-protocol analysis, 113 patients qualified using acetate tracings but only 82 qualified using photographs. Prior animal studies suggested that collagen alone would have little effect on healing and would serve as a negative control. Surprisingly trends for increased incidence of complete closure were observed for both GAM501 (41%) and FCG (45%) vs. Standard of Care (31%). By photographic data, Standard of Care had no significant effect on change in wound radius (mm/week) from during Run-in to Week 1 (-0.06 ± 0.32 to 0.78 ± 1.53, p=ns) but both FCG (-0.08 ± 0.61 to 1.97 ± 1.77, p<0.002) and GAM501 (-0.02 ± 0.58 to 1.46 ± 1.37, p<0.002) significantly increased healing rates that gradually declined over subsequent weeks. Both GAM501 and FCG appeared to be safe and well tolerated, and alternate dosing schedules hold promise to improve overall complete wound closure in adequately powered trials.
authors.affiliation: Affiliated Foot Surgeons, New Haven, Connecticut, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Blume
authors.forename: Vickie R
authors.initials: VR
authors.lastname: Driver
authors.forename: Arthur J
authors.initials: AJ
authors.lastname: Tallis
authors.forename: Robert S
authors.initials: RS
authors.lastname: Kirsner
authors.forename: Roy
authors.initials: R
authors.lastname: Kroeker
authors.forename: Wyatt G
authors.initials: WG
authors.lastname: Payne
authors.forename: Soma
authors.initials: S
authors.lastname: Wali
authors.forename: William
authors.initials: W
authors.lastname: Marston
authors.forename: Cyaandi
authors.initials: C
authors.lastname: Dove
authors.forename: Robert L
authors.initials: RL
authors.lastname: Engler
authors.forename: Lois A
authors.initials: LA
authors.lastname: Chandler
authors.forename: Barbara K
authors.initials: BK
authors.lastname: Sosnowski
mesh_terms: D000256:Adenoviridae / Q000235:genetics*; D043925:Angiogenesis Inducing Agents / Q000008:administration & dosage; D000077214:Becaplermin; D003094:Collagen / Q000008:administration & dosage* / Q000138:chemical synthesis* / Q000494:pharmacology* / Q000627:therapeutic use*; D017719:Diabetic Foot / Q000503:physiopathology* / Q000628:therapy*; D005782:Gels; D015316:Genetic Therapy / Q000379:methods*; D005822:Genetic Vectors / Q000008:administration & dosage; D006801:Humans; D010982:Platelet-Derived Growth Factor / Q000008:administration & dosage; D020574:Proto-Oncogene Proteins c-sis; D014945:Wound Healing / Q000187:drug effects* / Q000528:radiation effects
chemical_list: D043925:Angiogenesis Inducing Agents; D005782:Gels; D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; D000077214:Becaplermin; D003094:Collagen